The Evaluation of VAD InterVEntion Before Inotropic Therapy (REVIVE-IT)
This study is not yet open for participant recruitment.
Verified May 2013 by University of Michigan
Sponsor:
University of Michigan
Collaborators:
Thoratec Corporation
Information provided by (Responsible Party):
Francis D. Pagani, University of Michigan
ClinicalTrials.gov Identifier:
NCT01369407
First received: June 1, 2011
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
This is a randomized trial of the HeartMate II® Left Ventricular Assist System (LVAS) versus best medical therapy in patients with advanced heart failure (HF) and whose illness is not severe enough to qualify for transplant or permanent left ventricular assist device (LVAD) therapy based on current guidelines.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Device: HM II® (HeartMate II® LVAD) Other: OMM (Optimal Medical Management) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Randomized Evaluation of VAD InterVEntion Before Inotropic Therapy (REVIVE-IT) |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- Composite outcome of Survival, Freedom from moderately disabling stroke (defined as Modified Rankin Scale (MRS) ≥ 3) and Improvement of 6 Minute Walk Test distance by ≥75 meters from pre-randomization baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Moderately disabling (MRS ≥3) stroke-free survival with functional improvement of the 6 Minute Walk Test distance by ≥ 75 meters from pre-randomization baseline evaluated at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Functional capacity [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assessed by: 6 Minute Walk test, peak oxygen consumption, % predicted peak V02, oxygen uptake efficiency slope, VE/VCO2 slope, anaerobic threshold, NYHA functional class
- Health-related Quality of Life and Health Utility [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assessed by completion of various instruments
- Neurocognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Heart failure-related adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Worsening heart failure resulting in non-elective hospitalization, emergency department visit, urgent clinic visit at which intravenous therapy is administered.
- Hospital Readmission [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Cost and cost-effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Major adverse events (as defined in the protocol) in LVAD and OMM arms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Frequency of "Change of Therapy" to LVAD in the OMM arm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Frequency of heart transplantation in the OMM and LVAD arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Moderately disabling (MRS ≥3) stroke-free survival with functional improvement of the 6 Minute Walk Test distance by ≥75 m from pre-randomization baseline evaluated after consideration of "positive" and "negative" events. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Moderately disabling (MRS ≥3) stroke-free survival with functional improvement of the 6 Minute Walk Test distance by ≥ 75 meters from pre-randomization baseline evaluated after adjusted for within site correlation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Enrollment feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Stroke/TIA [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Incidence of stroke
- Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Moderately disabling (MRS ≥3) stroke-free survival with functional improvement of the 6 Minute Walk Test distance by ≥75 m from pre-randomization baseline evaluated after consideration of "positive" and "negative" events. [ Time Frame: 1 years ] [ Designated as safety issue: No ]
- Moderately disabling (MRS ≥3) Stroke- free days alive out of the hospital (from time of enrollment) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Stroke-free days (MRS=0) alive out of the hospital (from time of enrollment) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: HM II® (HeartMate II® LVAD)
Implantation of HM II® (HeartMate II® LVAD)
|
Device: HM II® (HeartMate II® LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
Other Name: Left Ventricular Assist Device
|
|
OMM (Optimal Medical Management )
OMM (Optimal Medical Management) as defined by current, evidenced-based heart failure practice standards including ACE inhibitors or ARB, a beta blocker and an aldosterone antagonists.
|
Other: OMM (Optimal Medical Management)
Optimal Medical Management as defined by current, evidenced-based heart failure practice standards including ACE inhibitors or ARB, a beta blocker and an aldosterone antagonists.
Other Name: Medical Management
|
Detailed Description:
REVIVE-IT is a two-part study consisting of a trial and a registry. The REVIVE-IT Trial is a prospective, randomized, open-label, multicenter trial, evaluating the HeartMate II® LVAS versus a control group consisting of optimal medical management (OMM) in selected non-inotrope dependent, ambulatory, moderately advanced heart failure patients who are not candidates for heart transplantation based upon assessment of comorbidities and age.
Patients are randomized to HeartMate II® LVAS or OMM in a 1:1 ratio and will be followed for 2 years. A staged enrollment plan will be used to ensure the safety of the study subjects receiving the HeartMate II® LVAS.
Patients will be entered into a prospective, observational, multi-center registry to collect information on heart failure and to evaluate how this information is related to the course of the illness over a 2 to 5 year period.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Ambulatory patient with chronic systolic heart failure ( documented HF symptoms ≥ 12 months; last documented LVEF ≤ 35%) and:
- Stable predominantly NYHA class III symptoms for the 3 months prior to study enrollment and up through randomization
- Receiving maximally-titrated doses of an ACE inhibitor or ARB, a beta-blocker and aldosterone antagonist, for at least 3 months prior to study enrollment, unless not tolerated or contraindicated; no dose adjustments for at least 30 days prior to study enrollment and up through randomization
- ≤ 1 heart failure-related hospitalization within the previous 6 months, with no heart failure-related hospitalization occurring within the 30 days prior to study enrollment and up through randomization
- No history of inotrope use within the 3 months prior to study enrollment and up through randomization
- Age ≥ 21 years
CRT/ICD entry criteria:
- If QRS duration ≥ 150 msec, in the presence of a left bundle branch block, the patient must have a CRT-D device (unless at least 1 prior attempt failed or compelling clinical contraindication, in which case patient must have an ICD)
- Patients who qualify for CRT or CRT-D must have it for ≥ 90 days prior to study enrollment
- If QRS duration < 150 msec, patient must have an ICD
- Patients who qualify for ICD must have it for ≥ 30 days prior to study enrollment
- BSA ≥ 1.2 m2
- Not a candidate for heart transplantation as determined by the Clinical Site Heart Transplant Committee
- The Seattle Heart Failure Model Score is ≥ 1.5
- LVEF ≤35% by transthoracic echocardiogram
- Peak exercise oxygen consumption is ≥ 35% and ≤ 55% of predicted and ≤ 16 ml/Kg/min in males or ≤ 14 ml/Kg/min in females by cardiopulmonary exercise testing
- 6 Minute Walk Test distance is ≤ 350 meters
- Low risk for right heart failure
Exclusion Criteria:
- Patient unable or unwilling to give informed consent or with high risk of noncompliance with study requirements
- Ongoing alcohol or drug abuse
- Participation in any other investigational study that may affect the outcome of the REVIVE-IT Trial
- Severe illness, other than heart disease, that would limit the patient's life expectancy to less than 2 years
- Acute STEMI within 3 months prior to study enrollment or between enrollment and randomization
- Pregnant females or women of child bearing-age who are not willing to use contraception
- Patient with a Body Mass Index > 45 kg/m2
- Any condition other than heart failure (e.g., arthritic, orthopedic, neuromuscular, neurologic) that is likely to substantially impair ability to achieve study's exercise endpoint
- Existence of any ongoing mechanical circulatory support including intra-aortic balloon counterpulsation, implantable or extracorporeal ventricular assist device, or ECMO
- Known history of positive heparin antibody AND positive serotonin release assay or postoperative use of warfarin or intolerance to anticoagulant or antiplatelet therapies
- History of a solid organ transplant, listed for a heart transplant or anticipated need for other solid organ transplant
- Patients with mechanical prosthetic aortic valve or requiring planned aortic valve replacement or closure of the aortic valve annulus at the time of LVAD surgery
- Patients with mechanical prosthetic mitral valve or requiring planned mitral valve procedure at the time of LVAD surgery.
- Etiology of heart failure due to hypertrophic cardiomyopathies, restrictive cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis, uncorrected thyroid disease, congenital heart disease with significant structural abnormalities
- Medical conditions or technical obstacles that would pose an inordinately high surgical risk in the judgment of the certified surgeon
- Active systemic infection
- Significant history of cerebral vascular disease
- Significant renal dysfunction
- Significant liver dysfunction
- Serum albumin < 3.0 g/dl
- Patients at risk of coagulopathy
- Significant pulmonary disease
- Peripheral vascular disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369407
Contacts
| Contact: Kathleen Granlund | 734-763-1741 | kemarsh@umich.edu |
| Contact: Huwaida Bulhan-Betts | 734-763-0597 | huwaidab@umich.edu |
Locations
| United States, Alabama | |
| University of Alabama - (Birmingham) | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: Salpy Pamboukian, MD | |
| Principal Investigator: William Holman, MD | |
| United States, Georgia | |
| Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Javed Butler, MD, MPH | |
| Principal Investigator: J. David Vega, MD | |
| United States, Illinois | |
| University of Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Savitri Fedson, MD | |
| Principal Investigator: Valluvan Jeevanandam, MD | |
| Advocate Christ Medical Center | Not yet recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Principal Investigator: William Cotts, MD | |
| Principal Investigator: Antone Tatooles, MD | |
| United States, Indiana | |
| St. Vincent Heart Center of Indiana | Not yet recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Principal Investigator: Mary Norine Walsh, MD, FACC | |
| Principal Investigator: Christopher Salerno, MD | |
| United States, Kentucky | |
| University of Louisville | Not yet recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: Emma Birks, MD, PhD | |
| Principal Investigator: Mark Slaughter, MD | |
| United States, Michigan | |
| University of Michigan | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Todd Koelling, MD | |
| Principal Investigator: Matthew Romano | |
| United States, Minnesota | |
| Abbott-Northwestern | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Principal Investigator: David Feldman, MD, PhD | |
| Principal Investigator: Louis B Louis, IV, MD | |
| University of Minnesota | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55944 | |
| Principal Investigator: Peter Eckman, MD | |
| Principal Investigator: Ranjit John, MD | |
| United States, Missouri | |
| Washington University | Not yet recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: Gregory Ewald, MD | |
| Principal Investigator: Scott Silvestry, MD | |
| United States, New York | |
| Montefiore Medical Center | Not yet recruiting |
| Bronx, New York, United States, 10467 | |
| Principal Investigator: J. Julia Shin, MD | |
| Principal Investigator: Daniel Goldstein, MD | |
| Columbia University | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Ulrich Jorde, MD | |
| Principal Investigator: Yoshifumi Naka, MD, PhD | |
| United States, North Carolina | |
| Duke University | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Joseph Rogers, MD | |
| Principal Investigator: Carmelo Milano, MD | |
| United States, Ohio | |
| Cleveland Clinic | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Randall Starling, MD | |
| Principal Investigator: Nader Moazami, MD | |
| United States, Oklahoma | |
| INTEGRIS Health Advanced Cardiac Care | Not yet recruiting |
| Oklahoma, Oklahoma, United States, 73112 | |
| Principal Investigator: James Long, MD, PhD | |
| Principal Investigator: Douglas Horstmanshof, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: J. Eduardo Rame, MD | |
| Principal Investigator: Michael Acker, MD | |
| University of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Dennis McNamara, MD | |
| Principal Investigator: Christian Bermudez, MD | |
| United States, Texas | |
| The Methodist Hospital | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Jerry Estep, MD | |
| Principal Investigator: Brian Bruckner, MD | |
Sponsors and Collaborators
University of Michigan
Thoratec Corporation
Investigators
| Principal Investigator: | Keith Aaronson, MD, MS | University of Michigan |
| Principal Investigator: | Francis D Pagani, MD PhD | University of Michigan |
| Principal Investigator: | Robert Kormos, MD | University of Pittsburgh |
| Study Chair: | Doug Mann, MD | University of Washington - St. Louis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Francis D. Pagani, Professor of Surgery, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01369407 History of Changes |
| Other Study ID Numbers: | REVIVE-IT, HHSN268201100026C |
| Study First Received: | June 1, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Heart failure Heart Diseases left ventricular assist device ventricular dysfunction heart-assist devices ventricular assist device Heart Failure NYHA class III |
HF Cardiovascular Diseases LVAD optimal medical management HeartMate II medical management |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Aldosterone Antagonists Angiotensin-Converting Enzyme Inhibitors Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013